# K180408: U60 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Apr 13, 2018 after 58 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K935595 (1995). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173003: U50 Diagnostic Ultrasound System, Edan Instruments, Inc. (2017) Summary page 16.

## Indications for use
The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients’ ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

Source page: https://510kreport.com/device/K180408
Methodology: https://510kreport.com/methodology